Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
|Lung Cancer||Procedure: computed tomography Radiation: fludeoxyglucose F 18 Radiation: hypofractionated radiation therapy Radiation: stereotactic radiosurgery||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer|
- To establish the maximally tolerated dose of CyberKnife® radiosurgery in patients with medically inoperable clinical Tl-3 N0 M0 NSCLC [ Time Frame: 6 weeks ]
- Relationship between PET response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging [ Time Frame: before treatment and at 1, 3, 6, and 12 months after treatment ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||March 2018|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Procedure/Surgery: computed tomography Standard CT scans
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
Procedure: computed tomography
Standard CT scansRadiation: fludeoxyglucose F 18
standard doses with CT scansRadiation: hypofractionated radiation therapy
4 doses over 2 weeksRadiation: stereotactic radiosurgery
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between PET response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852644
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Lisa A. Kachnic, MD||Boston Medical Center|